Reported May 8, 2019 · Terminated
cobas e 801 immunoassay analyzer
Roche Diagnostics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas e 801 immunoassay analyzer
- Lot codes and dates
- All units may experience this issue.
- Amount recalled
- 149
Where it was sold
Why it was recalled
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
This product could cause temporary or reversible health problems — stop using it.
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